FDA recall D-0578-2023

Product

Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01

Reason for recall

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Distribution

Product was distrituded to three direct account in PA.

Key facts

Status

Ongoing

Initiation date

2023-05-01

Report date

2023-05-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0578-2023